BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1926147 · Received November 8, 2010

    Report

    Report Number
    1926147
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 8, 2010
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    FIVE DIFFERENT REDDICK CATHETERS THAT WERE OPENED HAD A HOLE IN THE BALLOON PORTION OF THE CATHETER RENDERING THEM UNUSEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER GBZ LEMAITRE VASCULAR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *